OBJECTIVE: To estimate the effectiveness, cost effectiveness (to be reported elsewhere), and safety of pharmacy independent prescribers in care homes.
DESIGN: Cluster randomised controlled trial, with clusters based on triads of a pharmacist independent prescriber, a general practice, and one to three associated care homes.
SETTING: Care homes across England, Scotland, and Northern Ireland, their associated general practices, and pharmacy independent prescribers, formed into triads.
PARTICIPANTS: 49 triads and 882 residents were randomised. Participants were care home residents, aged ≥65 years, taking at least one prescribed drug, recruited to 20 residents/triad.
INTERVENTION: Each pharmacy independent prescriber provided pharmaceutical care to approximately 20 residents across one to three care homes, with weekly visits over six months. Pharmacy independent prescribers developed a pharmaceutical care plan for each resident, did medicines reviews/reconciliation, trained staff, and supported with medicines related procedures, deprescribing, and authorisation of prescriptions. Participants in the control group received usual care.
MAIN OUTCOMES MEASURES: The primary outcome was fall rate/person at six months analysed by intention to treat, adjusted for prognostic variables. Secondary outcomes included quality of life (EQ-5D by proxy), Barthel score, Drug Burden Index, hospital admissions, and mortality. Assuming a 21% reduction in falls, 880 residents were needed, allowing for 20% attrition.
RESULTS: The average age of participants at study entry was 85 years; 70% were female. 697 falls (1.55 per resident) were recorded in the intervention group and 538 falls (1.26 per resident) in the control group at six months. The fall rate risk ratio for the intervention group compared with the control group was not significant (0.91, 95% confidence interval 0.66 to 1.26) after adjustment for all model covariates. Secondary outcomes were not significantly different between groups, with exception of the Drug Burden Index, which significantly favoured the intervention. A third (185/566; 32.7%) of pharmacy independent prescriber interventions involved medicines associated with falls. No adverse events or safety concerns were identified.
CONCLUSIONS: Change in the primary outcome of falls was not significant. Limiting follow-up to six months combined with a small proportion of interventions predicted to affect falls may explain this. A significant reduction in the Drug Burden Index was realised and would be predicted to yield future clinical benefits for patients. This large trial of an intensive weekly pharmacist intervention with care home residents was also found to be safe and well received.
TRIAL REGISTRATION: ISRCTN 17847169.
We thank all participating care home residents, care homes, and general practices; the pharmacist independent prescribers; our patient and public involvement group; our pharmacist trainers and assessors; Norwich Clinical Trials Unit; Comprehensive Research Network Eastern; our sponsor (Norfolk and Waveney CCG); members of our Programme Steering Committee and Data Monitoring and Ethics Committee; our funders; and all the many other people who supported the delivery of the programme of research that culminated in this trial.
Funding: This work was funded by National Institutes of Health Research (NIHR) through their Programme Grant for Applied Research (PGfAR) stream (RP-PG-0613-20007). The funder had no role in design, data collection, data analysis, data interpretation, or writing of this paper.
Data Availability StatementData availability statement
De-identified participant data, including primary, secondary, and patient reported outcome data, interview transcripts, prescription data, protocol, and statistical analysis plan, are available on request from DW (email@example.com), LS (firstname.lastname@example.org), and Norfolk and Waveney Integrated Care Board (NWICB) research office (nwicb.RandDoffice@nhs.net). Reuse of the CHIPPS dataset will be made available on reasonable request for the purpose of improving patient care in health and social care and will be subject to completion of a data sharing agreement between NWICB, the University of East Anglia, and the third-party organisation.
- Aged, 80 and over
- Quality of Life
- Northern Ireland
- Pharmaceutical Services